SENSITITRE 18 – 24 HOUR SUSCEPTIBILITY PLATE


Device Classification Name

manual antimicrobial susceptibility test systems

510(k) Number K073653
Device Name SENSITITRE 18 – 24 HOUR SUSCEPTIBILITY PLATE
Applicant
TREK DIAGNOSTIC SYSTEMS, INC.
982 keynote circle suite 6
cleveland, 
OH 
44131

Applicant Contact cynthia c knapp
Correspondent
TREK DIAGNOSTIC SYSTEMS, INC.
982 keynote circle suite 6
cleveland, 
OH 
44131

Correspodent Contact cynthia c knapp
Regulation Number 866.1640
Classification Product Code
JWY  
Subsequent Product Code
LRG  
Date Received 12/26/2007
Decision Date 03/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No